(30 days)
K0902037
No
The summary describes a system for collecting and reporting physiological data and patient status, but there is no mention of AI or ML being used for data analysis, interpretation, or decision-making. The system appears to rely on direct measurement and reporting of vital signs and bed occupancy.
No
This device is intended for continuous measurement of heart rate and respiratory rate, and for fall prevention protocols, but it does not treat or cure any condition.
No
The device is intended for "continuous measurement of heart rate, respiratory rate, and as an integral part of fall prevention protocols," which are monitoring and surveillance functions, not diagnostic. While it collects and reports patient medical information, the primary function described is vigilance and fall prevention, not identifying or confirming a disease or condition.
No
The device description explicitly states it is composed of hardware components including a bedside unit (Display), a sensor array (mattress coverlet), and a LifeBed Controller.
Based on the provided information, the LifeBed Network Patient Vigilance System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of disease or conditions.
- LifeBed Network Function: The LifeBed Network Patient Vigilance System measures physiological parameters (heart rate and respiratory rate) and patient presence directly from the patient's body using a sensor array in a mattress coverlet. It does not analyze specimens taken from the body.
- Intended Use: The intended use is for continuous measurement of vital signs and as part of fall prevention protocols, which are direct patient monitoring and safety functions, not laboratory analysis of specimens.
Therefore, the LifeBed Network Patient Vigilance System falls under the category of a patient monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LifeBed Network Patient Vigilance System is intended for use with adult patients by health care professionals in the continuous measurement of heart rate, respiratory rate, and as an integral part of fall prevention protocols.
Product codes
74DRT
Device Description
This submission is an update to the LifeBed Network Patient Vigilance System (K083534), incorporating three changes to the software of the LifeBed Controller:
- -A software delay in the reporting of physiologic data has been removed.
- . The "dashboard" screen has been modified to display the current heart and respiratory rate, a historical graph of the rates, and the currently active alerts.
- The time intervals of available reports have been modified from a range of eight hours to one month to a range of one hour to one week
Except for the LifeBed Controller, no changes to the software of any other component of the system have been made, and no changes to any hardware component of the system have been made.
This version of the LifeBed Network Patient Vigilance System is compatible with the Vigilance Display (K0902037).
The LifeBed Network Patient Vigilance System ("LifeBed Network") is composed of a bedside unit (either a LifeBed Display or Vigilance Display, generically referred to as a Display), a sensor array packaged in the form of a mattress coverlet, and the LifeBed Controller. The LifeBed Displays are optionally equipped with a wireless adapter.
The LifeBed Network Patient Vigilance System collects, stores, and reports patient medical and status information.
Each Display is a bedside unit that collects and processes data from a sensor array on the patients' bed. It reports patient heart rate, respiratory rate, whether the patient is in bed, and any alerts. The configuration of a Display may be changed on the Display or remotely from the LifeBed Network.
The Displays are connected to the LifeBed Controller via a TCP/IP network which is provided by the customer. This network may be wired (using Ethernet), or wireless (using WiFi) as required by the facility.
The hub of the LifeBed Network is the LifeBed Controller'), which serves one unit (e.g., a hospital ward). From the Controller a user has access to the collected information and the ability to view and modify the configuration of connected Displays.
The LifeBed Network provides an interface which may be used to integrate with a Clinical Information System (CIS). When used in this way an auxiliary adapter isolates and translates the protocols between the LifeBed Network and the CIS. This interface allows the collected data and stored configuration for the Displays.
The LifeBed Network centralizes information access and configuration for a group of Displays. It DOES NOT change the manner in which alerts are communicated by the Display to the Nurse Call system of the hospital.
All user access to the LifeBed Network is constrained by a security system. Each user is authenticated by a user name and password and their ability to access data is controlled by their assigned role.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
health care professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
No clinical trials were performed in support of this submission.
All verification and validation testing conducted demonstrate that this release of the LifeBed Network Patient Vigilance System is substantially equivalent to the prior release (K092037).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K0902037
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
APR 1 5 2010
Submitted By
Contact: Date Summary Prepared Trade Name Common/Classification Name
Substantially Equivalent Devices
Hoana Medical, Inc. 828 Fort Street Mall, Suite 620 Honolulu, HI 96813 Phone: (808) 523-[????] Fax: (808) 523-5480
LifeBed Network Patient Vigilance System Monitor, Cardiac 74DRT, 870.2300 LG1 Patient Vigilance System (K052446)
LifeBed Patient Vigilance System (K082366)
LifeBed Network Patient Vigilance System (K083534)
Verathon, Corp BVI 9400 with ScanPoint (K071217) Diagnostic Ultrasound BVM6500 with ScanPoint (K030763)
Description of the LifeBed Network Patient Vigilance System
This submission is an update to the LifeBed Network Patient Vigilance System (K083534), incorporating three changes to the software of the LifeBed Controller:
- -A software delay in the reporting of physiologic data has been removed.
- . The "dashboard" screen has been modified to display the current heart and respiratory rate, a historical graph of the rates, and the currently active alerts.
- The time intervals of available reports have been modified from a range of eight hours to one month to a range of one hour to one week
Except for the LifeBed Controller, no changes to the software of any other component of the system have been made, and no changes to any hardware component of the system have been made.
This version of the LifeBed Network Patient Vigilance System is compatible with the Vigilance Display (K0902037).
The LifeBed Network Patient Vigilance System ("LifeBed Network") is composed of a bedside unit (either a LifeBed Display or Vigilance Display, generically referred to as a Display), a sensor array packaged in the form of a mattress coverlet, and the LifeBed Controller. The LifeBed Displays are optionally equipped with a wireless adapter.
The LifeBed Network Patient Vigilance System collects, stores, and reports patient medical and status information.
1
Each Display is a bedside unit that collects and processes data from a sensor array on the patients' bed. It reports patient heart rate, respiratory rate, whether the patient is in bed, and any alerts. The configuration of a Display may be changed on the Display or remotely from the LifeBed Network.
The Displays are connected to the LifeBed Controller via a TCP/IP network which is provided by the customer. This network may be wired (using Ethernet), or wireless (using WiFi) as required by the facility.
The hub of the LifeBed Network is the LifeBed Controller'), which serves one unit (e.g., a hospital ward). From the Controller a user has access to the collected information and the ability to view and modify the configuration of connected Displays.
The LifeBed Network provides an interface which may be used to integrate with a Clinical Information System (CIS). When used in this way an auxiliary adapter isolates and translates the protocols between the LifeBed Network and the CIS. This interface allows the collected data and stored configuration for the Displays.
The LifeBed Network centralizes information access and configuration for a group of Displays. It DOES NOT change the manner in which alerts are communicated by the Display to the Nurse Call system of the hospital.
All user access to the LifeBed Network is constrained by a security system. Each user is authenticated by a user name and password and their ability to access data is controlled by their assigned role.
Indications for Use
The LifeBed Network Patient Vigilance System is intended for use with adult patients by health care professionals in the continuous measurement of heart rate, respiratory rate, and as an integral part of fall prevention protocols.
Electrical, Mechanical, and EMC Testing for the LifeBed Network Patient Vigilance System
No changes were made to the hardware of any component of the LifeBed Network; this submission relies upon the testing done for the LG1 Patient Vigilance System (K052446), LifeBed Patient Vigilance System (K082366), and the LifeBed Network Patient Vigilance System (K083534)
Biocompatibility Testing
No changes were made to patient contact surfaces; no biocompatibility testing was performed as part of this submission.
Clinical Testing
No changes were made to the LifeBed Patient Vigilance System (KO82366) which contains the algorithm and control of the patient interface. The LifeBed Network only adds the networking and data collection capabilities. No clinical trials were performed in support of this submission.
2
K100745
p3/3
Conclusion
All verification and validation testing conducted demonstrate that this release of the LifeBed Network Patient Vigilance System is substantially equivalent to the prior release (K092037).
.
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3
DEPARTMENT OF HEALTH & HUMAN SERVICES
ﺔ ﺍﻟﺘﻲ ﺗﻘﺮﻳﺒﺎ ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a human figure embracing a bird, symbolizing the department's mission to protect and promote the health and well-being of Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
APR 1 5 2010
Hoana Medical, Inc. c/o Ms. Cindy Green Regulatory Affairs/Quality Assurance Consultant North West Regulatory Support, LLC 21031 SE 202"d Street Renton, WA 98058
Re: K100745
LifeBed Network Patient Vigilance System Regulatory Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: II (two) Product Code: 74 DRT Dated: March 3, 2010 Received: March 16, 2010
Dear Ms. Green:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 - Ms. Cindy Green
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: LifeBed Network Patient Vigilance System
Indications For Use:
The LifeBed Network Patient Vigilance System is intended for use with adult patients by health care professionals in the continuous measurement of heart rate, respiratory rate, and as an integral part of fall prevention protocols.
x Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K100745 |
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